Le Lézard
Classified in: Health, Science and technology, Business
Subjects: ERN, CCA, ERP

PTC Therapeutics Reports Second Quarter 2019 Financial Results and Provides a Corporate Update


SOUTH PLAINFIELD, N.J., Aug. 6, 2019 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the second quarter ending June 30, 2019.

"Over the second quarter we've made important progress towards our strategic plan of building a robust diversified orphan drug franchise," said Stuart W. Peltz, Ph.D., CEO of PTC Therapeutics. "We believe that one of PTC's key differentiators is our ability to work across multiple scientific platforms to bring orphan products to patients. Our 5-year vision elucidates PTC's mission of bringing differentiated therapies to patients living with rare disorders that have limited or no treatment options. By fulfilling this mission, we will be creating value for all of our stakeholders."

Key Second Quarter and Other Corporate Highlights:

Commercial portfolio

Advancing gene therapy portfolio & infrastructure

Risdiplam remains on track for NDA submission with the FDA in 2H19

PTC re-iterates full year 2019 guidance:

Second quarter 2019 financial highlights:

Non-GAAP Financial Measures:

In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management's opinion, these non-GAAP financial measures are useful to investors and other users of PTC's financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company's future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.

Today's Conference Call and Webcast Reminder:

Today's conference call will take place at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 6594813. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company's website for two weeks.

About PTC Therapeutics, Inc.

PTC is a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to globally commercialize products is the foundation that drives investment in a robust pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. To learn more about PTC, please visit us on www.ptcbio.com and follow us on Facebook, on Twitter at @PTCBio, and on LinkedIn.

For More Information:
Investors:
Emily Hill
+ 1 (908) 912-9327
[email protected]

Media:
Jane Baj
+1 (908) 912-9167
[email protected]

Forward Looking Statements:

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this release, other than statements of historic fact, are forward-looking statements, including the information provided under the heading "PTC Re-iterates Full Year 2019 Guidance", including with respect to (i) 2019 net product revenue guidance and (ii) 2019 GAAP and non-GAAP R&D and SG&A expense guidance, and statements regarding: the future expectations, plans and prospects for PTC; expectations with respect to PTC's gene therapy platform, including any potential regulatory submissions; PTC's expectations with respect to the licensing, regulatory submissions and potential commercialization of Tegsedi and Waylivra; expansion of commercialization of Translarna and Emflaza and related regulatory submissions; advancement of PTC's joint collaboration program in SMA, including any potential regulatory submissions or royalty or milestone payments; PTC's strategy, future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.

PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for Emflaza and Translarna and any other product candidates that PTC may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving Emflaza prescription reimbursement; PTC's ability to complete a dystrophin study necessary to support a re-submission of its Translarna NDA for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) to the FDA, and PTC's ability to perform any necessary additional clinical trials, non-clinical studies, and CMC assessments or analyses at significant cost; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in the European Economic Area (EEA), including whether the European Medicines Agency (EMA) determines in future annual renewal cycles that the benefit-risk balance of Translarna authorization supports renewal of such authorization; PTC's ability to enroll, fund, complete and timely submit to the EMA the results of Study 041, a randomized, 18-month, placebo-controlled clinical trial of Translarna for the treatment of nmDMD followed by an 18-month open-label extension, which is a specific obligation to continued marketing authorization in the EEA; expectations with respect to the potential financial impact or PTC's ability to realize the anticipated benefits of the acquisition of Agilis and its gene therapy platform, including with respect to the business of Agilis and expectations with respect to the potential achievement of development, regulatory and sales milestones and contingent payments to the former Agilis equityholders with respect thereto and PTC's ability to obtain marketing approval of PTC-AADC and other product candidates acquired from Agilis, will not be realized or will not be realized within the expected time period; expectations with respect to the potential financial impact and benefits of the collaboration and licensing agreement with Akcea Therapeutics, Inc., including with respect to the timing of regulatory approval of Tegsedi and Waylivra in countries in Latin America and the Caribbean, the commercialization of Tegsedi and Waylivra, and PTC's expectations with respect to contingent payments to Akcea based on net sales and the potential achievement of regulatory milestones; the enrollment, conduct, and results of studies under the SMA collaboration and events during, or as a result of, the studies that could delay or prevent further development under the program, including any potential regulatory submissions with regards to risdiplam; significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition of its gene therapy pipeline, as well as other business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of Translarna, Emflaza, PTC-AADC, Tegsedi, Waylivra, risdiplam or any of PTC's other product candidates; PTC's scientific approach and general development progress; expectations with respect to the potential financial impact and benefits of its leased biologics facility and PTC's ability to satisfy its obligations under the terms of the lease agreement for such facility; PTC's ability to satisfy its obligations under the terms of the senior secured term loan facility with MidCap Financial; the sufficiency of PTC's cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the "Risk Factors" section of PTC's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including Translarna, Emflaza, PTC-AADC, Tegsedi, Waylivra or risdiplam.

The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

PTC Therapeutics, Inc.

Consolidated Statements of Operations

(In thousands, except share and per share data)




Three Months Ended June 30,


Six Months Ended June 30,



2019


2018


2019


2018

Revenues:









Net product revenue


$

85,476



$

68,170



$

138,530



$

124,151


Collaboration and grant revenue


46



573



575



654


Total revenues


85,522



68,743



139,105



124,805


Operating expenses:









Cost of product sales


3,211



2,572



5,587



5,616


Amortization of Acquired intangible assets


6,575



5,593



12,652



11,022


Research and development (1)


59,979



32,607



112,544



63,970


Selling, general and administrative (2)


49,215



33,545



89,760



66,514


Change in the fair value of deferred and contingent consideration


5,300



?



26,460



?


Total operating expenses


124,280



74,317



247,003



147,122


Loss from operations


(38,758)



(5,574)



(107,898)



(22,317)


Interest expense, net


(2,074)



(2,884)



(4,362)



(6,187)


Other (expense) income, net


(183)



(673)



(292)



332


Loss before income tax expense


(41,015)



(9,131)



(112,552)



(28,172)


Income tax expense


(774)



(389)



(1,350)



(610)


Net loss attributable to common stockholders


$

(41,789)



$

(9,520)



$

(113,902)



$

(28,782)











Weighted-average shares outstanding:









Basic and diluted (in shares)


55,912,748



46,137,833



57,113,141



46,257,397


Net loss per share?basic and diluted (in dollars per share)


$

(0.75)



$

(0.21)



$

(1.99)



$

(0.62)











(1) Research and development reconciliation









GAAP research and development


$

59,979



$

32,607



$

112,544



$

63,970


Less: share-based compensation expense


5,516



3,932



10,203



7,678


Non-GAAP research and development


$

54,463



$

28,675



$

102,341



$

56,292











(2) Selling, general and administrative reconciliation









GAAP selling, general and administrative


$

49,215



$

33,545



$

89,760



$

66,514


Less: share-based compensation expense


5,404



4,152



9,981



8,153


Non-GAAP selling, general and administrative


$

43,811



$

29,393



$

79,779



$

58,361






































 

 

 

PTC Therapeutics, Inc.

Summary Consolidated Balance Sheets

(in thousands, except share data)



June 30, 2019


December 31, 2018

Cash, cash equivalents and marketable securities


$

363,541



$

227,586


Total Assets


$

1,291,572



$

1,119,222







Total Debt


$

155,683



$

153,014


Total deferred revenue


15,802


13,438


Total liabilities


802,887



768,495







Total stockholders' equity (58,707,185 and 50,606,147 common shares issued and outstanding at June 30, 2019 and December 31, 2018 respectively)


$

488,685



$

350,727


Total liabilities and stockholders' equity


$

1,291,572



$

1,119,222







 

 

PTC Therapeutics, Inc.

Reconciliation of GAAP to Non-GAAP Projected Full Year 2019 R&D and SG&A Expense

(In thousands)



Low End of Range


High End of Range

Projected GAAP R&D and SG&A Expense


$

395,000



$

405,000


Less: projected non-cash, stock-based compensation expense


35,000



35,000


Projected non-GAAP R&D and SG&A expense


$

360,000



$

370,000







 

SOURCE PTC Therapeutics, Inc.


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